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Trial registered on ANZCTR


Registration number
ACTRN12623000466640
Ethics application status
Approved
Date submitted
21/12/2021
Date registered
5/05/2023
Date last updated
5/10/2024
Date data sharing statement initially provided
5/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
3-Dimensional Printing Assisted Masks in Children with Obstructive and Restrictive Airway Disease
Scientific title
Safety and Tolerability of 3-Dimensional Printing Assisted Non Invasive Ventilation Masks in Children with Obstructive and Restrictive Airway Disease
Secondary ID [1] 306079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
airway obstruction
 324730 0
respiratory failure 324731 0
non invasive ventilation 324732 0
Condition category
Condition code
Respiratory 322180 322180 0 0
Sleep apnoea
Respiratory 322181 322181 0 0
Chronic obstructive pulmonary disease
Respiratory 322182 322182 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A digital image scanner will be used to create an accurate image of the patient's facial contour - This usually takes less than 5 minutes. This will then be made into a 3D printing assisted mask cushion made with medical grade silicone (ie the same material used for the standard NIV (non invasive ventilation) masks), fully customised to the contours of the patient’s face. These mask cushions are attached to a standard NIV mask and used with a CPAP (continuous positive airway pressure)/BiPAP (bilevel positive airway pressure) machine in place of a standard mask.

Assessment and monitoring of the effectiveness of NIV will occur exactly as per standard clinical care in the NIV initiation clinic. Patients are seen in the NIV clinic by a respiratory physician and nurse to fit the mask, determine appropriate NIV settings and the mask is fitted and NIV tested with the patient awake. The duration of the fitting and testing session usually takes 5-10 minutes.

The masks will be fitted as soon as they are available, as part of their routine clinical care with the respiratory team as for the conventional NIV masks. Their original off the shelf mask will be kept to be used as a backup. The parents and or mature minor will be sent reminders via email to complete the questionnaires according to the protocol. Patients will then wear the mask when sleeping. Patients will be asked to wear the mask for at least 2 weeks, and up to 12 months or longer (ie used as the replacement mask) if they tolerate it.

Adherence to intervention will be monitored via the questionnaires, as well as the data downloaded from their NIV machine (data will be recorded when the machine is used which is routine for all these machines).
Intervention code [1] 322485 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329959 0
To assess the:
1) Preliminary safety (ie presence of pressures sores, skin reaction and effect on facial growth)
- This is assessed via the S3-NIV questionnaire is modified from Dupuis-Lozeron E et al which measures the fit and comfort of the mask, compared to the conventional masks.
Timepoint [1] 329959 0
These questionnaires will be repeated at 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.
Primary outcome [2] 334629 0
2) Tolerability (ie fit and comfort) of the customised 3D printed NIV masks compared to the conventional masks.
- This is subjectively measured via these questionnaires: The OSA (obstructive sleep apnea)-18 Quality of Life Survey which measures the child’s quality of life, and Paediatric Sleep Questionnaire which measures the impact of the respiratory failure
- This is objectively measured via data that is downloaded from their NIV machine regarding:
a) Usage days (=4 hours and <4 hours; a measure of compliance)
b) Average usage hours (a measure of compliance)
c) Median pressure (cmH20; the pressure of air needed to overcome their lung disease)
d) Median leaks (L/min; the amount of air leak)
e) Apnoea Hypopnoea Index (AHI; the degree of obstruction with the mask)
Timepoint [2] 334629 0
These questionnaires will be repeated at 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.
Secondary outcome [1] 404445 0
1) To evaluate the preliminary performance:
- Changes in compliance assessed with study-specific questionnaire
- Average AHI (Apnea hypopnea index) assessed via data linkage to NIV machine
compared with their previous use of conventional masks
Timepoint [1] 404445 0
All the questionnaires and NIV downloaded data will be repeated at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.
Secondary outcome [2] 421320 0
2) To evaluate the preliminary performance:
- Average AHI (Apnea hypopnea index) assessed via data linkage to NIV machine
compared with their previous use of conventional masks
Timepoint [2] 421320 0
All the questionnaires and NIV downloaded data will be repeated at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.
Secondary outcome [3] 421459 0
3) To evaluate the feasibility of the study based on recruitment rate, retention rate and the ability of patients to complete the questionnaires.
Timepoint [3] 421459 0
This is assessed at the end of the study via audit of the study records:
- Recruitment rate: Total number of patients recruited over the study period
- Retention rate: The number of patients that stayed in the study over the study period
- Ability of patients to complete the questionnaires: The number of completed questionnaires at baseline, 2 weeks, 1-, 3-, 6- and 12-month post mask fitting.

Eligibility
Key inclusion criteria
1) Inability to tolerate conventional masks due to: Fit, leak, hypoxemia, and pressure sores.
2) Ongoing need for NIV masks based on respiratory physician assessment, qualitatively based on the comfort, leak, pressure areas, as well as quantitative data from the NIV machine regarding the compliance and AHI. A formal polysomnography may be requested if further quantification of the need for NIV is required.
3) Respiratory physician assessment to ensure that non-compliance is due to inability to tolerate NIV masks secondary to poor fit, measured via the Mask Fit & Comfort questionnaire, and the objective downloadable data where they are non compliant with its use.
4) Exhausted the 2 commercially available mask options at Perth Children’s Hospital.
5) Consent from caregivers and or mature minors
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients over the age of 18 years old
2) Patients not needing NIV masks
3) Patients for whom commercially available NIV masks fit well
4) Allergic skin reaction to commercially available NIV masks (medical grade silicone)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive analysis is the main statistical method due to the small number anticipated. Continuous data will be reported as means and standard deviations or medians and interquartile ranges if the distribution is skewed. Categorical data will be reported as frequencies and percentages. QoL outcomes will be plotted using a line graph (outcome measure over time) for each individual looking for trends.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2029
Actual
Date of last data collection
Anticipated
2/05/2030
Actual
Sample size
Target
10
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 36273 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310415 0
Hospital
Name [1] 310415 0
Perth Children's Hospital
Country [1] 310415 0
Australia
Funding source category [2] 310427 0
Government body
Name [2] 310427 0
East Metropolitan Health Service
Country [2] 310427 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital
Address
15 Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 311573 0
Government body
Name [1] 311573 0
East Metropolitan Health Service
Address [1] 311573 0
10 Murray St, Perth WA 6000
Country [1] 311573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310061 0
Child and Adolescent Health Services Ethics Comittee
Ethics committee address [1] 310061 0
15 Hospital Ave, Nedlands WA 6009
Ethics committee country [1] 310061 0
Australia
Date submitted for ethics approval [1] 310061 0
20/05/2021
Approval date [1] 310061 0
27/10/2021
Ethics approval number [1] 310061 0
RGS0253

Summary
Brief summary
Non-invasive ventilation (NIV) is a medical treatment that delivers pressurised air to the airways, reducing the effort of breathing and improving gas exchange. It is most commonly used in children to treat airway obstruction and respiratory failure. As everyone has a unique facial structure, a one-size-fits-all conventional NIV mask is not suitable for all children, especially those with cranio-facial abnormalities or; different facial sizes, structures and growths. Children often stop wearing their masks due to discomfort, making treatment in these patients challenging.

We aim to demonstrate that personalised mask is as safe as the conventional mask, will be more comfortable, resulting in improved compliance, and therefore clinical outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116354 0
Dr Jennifer Ha
Address 116354 0
Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009
Country 116354 0
Australia
Phone 116354 0
+61 8 64562222
Fax 116354 0
Email 116354 0
[email protected]
Contact person for public queries
Name 116355 0
Jennifer Ha
Address 116355 0
Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009
Country 116355 0
Australia
Phone 116355 0
+61 8 64562222
Fax 116355 0
Email 116355 0
[email protected]
Contact person for scientific queries
Name 116356 0
Jennifer Ha
Address 116356 0
Perth Children's Hospital
15 Hospital Ave, Nedlands WA 6009
Country 116356 0
Australia
Phone 116356 0
+61 8 64562222
Fax 116356 0
Email 116356 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect anonymity of patients


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14493Ethical approval    383324-(Uploaded-21-12-2021-05-58-31)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.